PKC

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Product code: PKC
Device name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device class: Class 2
21 CFR: 21 CFR 888.3660
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 19

FDA classification definition

Replacement of the humeral head for total anatomic shoulder arthroplasty

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Last three years. Most recent: 2026-05-01.

Number	Decision date	Applicant	Device name	Summary
K254154	2026-05-01	FX Shoulder Solutions, Inc.	FX V135 EASYTECH® Shoulder System	PDF
K252129	2025-10-03	Smith & Nephew, Inc.	AETOS Shoulder System Stemless Humeral Prosthesis	PDF
K243248	2024-12-23	Depuy Ireland UC	INHANCE INTACT	PDF
K241873	2024-12-11	Zimmer, Inc.	OsseoFit Stemless Shoulder System	PDF
K240716	2024-11-20	Smith & Nephew, Inc.	AETOS Shoulder System Stemless Humeral Prosthesis	PDF

5 summaries are archived here for direct download.

Official FDA classification page: PKC

Classification and pathway per current FDA publications. Data from openFDA (CC0).